Here's the table of contents for this week's Health Lawyers Weekly from the AHLA, a great member benefit that pulls together a lot good information from disparate sources:

Top Stories

OIG Finds $1.1 Billion In Improper Payments For Medicare ConsultationsMedicare paid approximately $1.1 billion more than it should have in 2001 for services billed as consultations, the Department of Health and Human Services Office of Inspector General (OIG) said in a new report, “Consultations In Medicare: Coding And Reimbursement” OEI-09-02-00030.At least 75% of services billed as consultations and paid by Medicare during 2001 did not meet program requirements, OIG said.

OIG Says DME Manufacturer’s Proposed Programs With Physicians Raise Significant Anti-Kickback ConcernsA durable medical equipment (DME) manufacturer’s proposal to offer physician practices two programs that would involve furnishing DME and orthotics to their patients poses a significant risk of fraud and abuse and could trigger administration sanctions under the Anti-Kickback Statute, the Department of Health and Human Services Office of Inspector General (OIG) said in Advisory Opinion No. 06-02 posted March 28.

Oops - looks like just about everyone is having difficulty figuring out the new Medicare Part D program, including HHS Secretary Leavitt's parents. Accourding to the Salt Lake Tribune,

Not even the senior parents of Washington's top health official are immune from headaches caused by the new Medicare drug plan. Dixie and Anne Leavitt - parents of Health and Human Services
Secretary Mike Leavitt - recently were forced to change Medicare plans
after learning that the one they chose imperiled their retiree medical
coverage.

The elder Leavitts joined the program last fall with some fanfare and help from their son. Anne Leavitt, 73, was quoted in The Salt Lake Tribune touting the online enrollment as "smooth," and a guaranteed money-saver.

Neither she nor Dixie, 76 - who made his fortune in the
insurance business - could be reached for comment on Thursday. But they
reportedly suffered no real lapse in coverage. Secretary Leavitt's
office confirmed that the couple signed up for another Medicare plan
through their insurer, Utah's Public Employee Health Plan.

But the blunder is sure to prove fodder for critics who have
labeled the drug benefit "plagued" with problems, from computer
failures to overcharging for prescriptions. Troubles have been most
acute for millions of low-income seniors and disabled people who were
automatically transferred from their state Medicaid plans into Medicare
plans that didn't cover their medications.

The KaiserNetwork.Org states that the Federal Trade Commission has issued subpoenas to 190 pharmaceutical companies. According to the story,

The Federal Trade Commission
on Wednesday announced that it plans to subpoena 190 drug companies in
an investigation of possible anti-competitive practices in the
pharmaceutical industry, the AP/Los Angeles Times reports. The subpoenas, which require approval from the Office of Management and Budget,
would be part of a probe into whether pharmaceutical companies are
suppressing competition by releasing authorized generic versions of
their own brand-name drugs to coincide with the introduction of
products from generic drug makers. Under federal law, after a generic
pharmaceutical company successfully challenges a patent held by a
brand-name manufacturer, it has six months of exclusivity to sell the
drug in the generic market by itself. However, a loophole allows
brand-name manufacturers to authorize their own generic versions, which
increasingly are entering the market at the beginning of the six-month
exclusivity period. Generic drug manufacturers depend on that
exclusivity period to recover their costs and make a profit, but with
authorized generics entering the generic market sooner, profit margins
are falling for generic manufacturers. FTC plans to study whether the
authorized-generic loophole benefits brand-name companies in the long
run by discouraging generic drug makers from challenging patents.
Lawmakers requested in May 2005 that the FTC conduct the investigation,
and a final report is due by late 2007 (Bridges, AP/Los Angeles Times, 3/30).

The New Scientist reports on a study that indicates that individuals who smoke may do so because they are getting up too early.

Till
Roenneberg at Ludwig Maximilians University in Munich and his
colleagues used questionnaires to assess the "chronotype" of more than
500 volunteers - a measure of how much of a night owl or early bird you
are. As with previous large studies, they found that the average person
prefers to sleep between 12.30 am and 8.30 am, although chronotypes
vary so widely that the latest owls are still awake when the earliest
larks are rising. . . .

Roenneberg
believes his finding could help explain why most people who take up
smoking begin as teenagers. Previous studies have shown that teenagers'
chronotypes creep later until early adulthood before receding again,
leaving them among the most likely to live beyond their chronotype's
means.

However,
there may be a solution. Roenneberg suggests making school and work
schedules flexible, as well as using bright light in the mornings to
help the body adapt to unnatural routines. While such changes might be
difficult, they could well save lives, as social jet lag may account
for a large chunk of the smoking population, he says.

Well, I think I better go get some more sleep because I don't want to start an expensive and deadly habit . . .[bm]

Today's NY Times reports that the American Heart Journal has released an article on its web site that will appear next week that questions whether intercessionary prayer has any healing effects. Indeed, the article suggests that patients who know they are being prayed for have a higher rate of complications, perhaps because their expectations are higher as a result of that knowledge. This may be the largest study yet to look at the question.

The focus of the study was prayer offered by strangers without the knowledge of the patient. The paper doesn't express an opinion about the power of prayer by patients themselves or by close family members. [tm]

Well, that didn't take long - Brian Leiter at Brian Leiter's Law School Reports has a critique of the latest US News rankings of law schools. After reviewing the current set of rankings, he states,

Not a crazy set of results, but if we assume reasonably enough that
"academic reputation" ought to track the quality of faculty and
students, then some schools (UC Davis, Washington & Lee, Duke,
Michigan, perhaps North Carolina, perhaps Northwestern) are too high,
while others (UC Hastings, Illinois, NYU, BU) are too low, relative to
the actual academic merits. (Addendum: It should go without saying, I hope, that these are my judgments about the relative
merits only: e.g., Michigan is "too high" in the sense that NYU is now
clearly better; and so on. Michigan can obviously have an outstanding
faculty, which it does (and even before adding
Laycock, Radin, et al.!), without it being sensible to rate Michigan on
a par with NYU. The same point applies to the other instances
mentioned.)

He has some other thoughts as well that you can review here. Thanks for Paul Caron for the cite. [bm]

Over at the Health Care Blog, Matthew Holt reviews a recent article by Brian Smedley, entitled, "Sliding Down the Back Side of the Health Care Quality Curve: Who's at Greatest Risk?" He discusses the rather mediocre medical care provided to all citizens in the United States and also addresses the racial and gender disparities in the quality of care. It is a great read and interesting points about what choices need to be made to ensure a better quality health care for all. [bm]

For all the latest on the Avian Flu - the always excellent Science section of the New York Times contains many interesting and informative articles about the potential for a pandemic: potentially yes here, and potentially no here; some of the latest testing, here; the impact on a variety of birds. [bm]

I know that these are not supposed to be important but it is always interesting to see where your school falls each year. So, here is an advanced look at the US News Rankings - thanks to Paul Caron at TaxProfBlog. I hope that you find them interesting . . .

Both Michael Schiavo, Terri's husband, and the Schindler's, Terri's parents, have both released books on the anniversary of her death. Unfortunately for both sides, the bitter feud does not seem to have been resvolved. For more information, ABC news has a brief story, which states,

Schiavo's book, "Terri: The Truth," is being released today, one day
before Bob and Mary Schindler's "A Life That Matters" hits stores.

In his book, Schiavo admits he's settling some scores. He unloaded his
feelings Sunday on NBC's "Dateline" in his first interview since his
wife died. Among his accusations is that Terri's family, including her
father, demanded the money from a malpractice award.

"First, he asked when the money was coming down, and then he asked me,
'How much money am I going to get?''' Schiavo told "Dateline."

"I said. … 'I'm giving it all to Terri.' Then with some anger in his
voice, he pointed at Terri and said, 'Well, how much is she going to
give me?' She's not going to give you anything. That money is entrusted
with a guardian."

On "Good Morning America," the Schindlers admitted there was a
disagreement over money. They said it was because they wanted the money
from the malpractice suit to go to Terri's rehabilitation and Schiavo
spent it on legal fees.

"The money Michael promised for Terri's therapy and rehabilitation. …
Instead it went to Michael's attorney to have Terri killed," said Bobby
Schindler, Terri's brother.

An ABC poll shows that 64% of Americans agree with Michael Schiavo's decision to remove the feeding tube (However, it is unclear to me how this question was asked - if people were saying that they believed the husband when he said that this was Terri's wish or whether they felt it was appropriate for him to make the decision for her). [bm]

Many
adults in the United States believe their federal administration is not
doing enough to help them with the cost of medical services, according
to a poll by Princeton Survey Research Associates for the Pew Research
Center for the People and the Press. 70 per cent of respondents think
the government spends too little on health care.

Asked
if they thought the government spends too much, too little or the right
amount on health care, it wasn't even close — 70% of poll respondents
said the government spends too little. Asked if they thought the
average American spends too much, too little or the right amount on
health care, the results were nearly identical — 65% said people spend
too much.

It's been like Grand Central Station keeping up with journal articles recently. Here's the latest: a symposium issue of the Loyola University Chicago Law Journal on "The Law of Death and Dying" (37 Loy. U. Chi. L.J. 279-454 (2006):

Colby, William H. From Quinlan to Cruzan to Schiavo: what have we learned? 37 Loy. U. Chi. L.J. 279-296 (2006). [L][W]

Cerminara, Kathy L. Critical essay: musings on the need to convince some people with disabilities that end-of-life decision-making advocates are not out to get them. 37 Loy. U. Chi. L.J. 343-384 (2006). [L][W]

Yesterday, I posted links and abstracts for the papers that have been posted to the SSRN Public Health Law and Policy web page in March (so far). Today, it's the same exercise, this time for papers on the SSRN Health Law web page. Links are to abstract pages, from which it is easy to get to the full paper (if one is available).

Abstract: After nearly twenty-five years on the bench, Justice Sandra Day O’Connor left the Supreme Court at the end of January 2006. There has been much discussion of Justice O’Connor’s decisions in areas such as federalism, the First Amendment’s Establishment Clause, and affirmative action, among other topics. But very little has been written about her important role in the development of federal constitutional law concerning the “right to die.”

This Essay seeks to fill this gap in the literature by exploring Justice O’Connor’s important concurring opinions in Cruzan and Glucksberg. I argue that these opinions created constitutional promises of a sort that remain unfulfilled as Justice O’Connor retires. I also explain why this need not have been the case while highlighting the real world consequences of the failure to live up to the promises.

Abstract: This essay, a revised version of the United States report on "Euthanasia" to be presented at the XVII International Congress of Comparative Law, surveys the state of the law, both decisional and statutory, on the permissibility of compassionately motivated actions to terminate human life. It deals with a range of legal categories, suicide, attempted suicide, euthanasia, assisted suicide and the termination of life-sustaining treatment. It highlights the deeply ambivalent attitudes held toward these actions in contemporary America and how this ambivalence has resulted in obscure and artificial distinctions.

Abstract: Retainer care arrangements allow patients to pay a fee directly to a physician’s office in order to obtain special access to care. Practices usually convert to retainer status by concentrating their attention on a small panel and dropping the majority of their patients. Proponents call retainer care a triumph of consumer-directed health care; opponents deride it as “boutique medicine.” Both sides are deploying a variety of legal tactics in order to attain their goals.

After surveying these conflicts, this article clarifies what is at stake by analyzing the three key features of retainer care: preventive care, queue-jumping, and amenity-bundling. Most commendably, retainer physicians are aggressively counseling their patients on how to avoid getting ill. More questionably, they are trading faster access to better health care for cash. Most troublingly, they are bundling medical care with unrelated amenity services.

Each of these "faces" of concierge care deserves a different legal response. This article develops a normative framework for tailored intervention. Regulators have taken some promising steps toward mitigating the worst aspects of retainer care conversions. However, taxation may be the only approach sufficiently targeted to reduce incentives for queue-jumping and amenity-bundling while promoting innovation in preventive care.

Abstract: Has science anything to tell us about responsibility? Addiction is a particularly interesting test case. Two fields of science, behavioral economics and neurophysiology have lately given us a great deal of information about addiction, much of which may be useful to the law. When it comes to addiction, unfortunately, the two fields seem to point in opposite directions.

Economics has provided us with models of addictive behavior based upon the supposition that addiction is the result of choice, a development that appears to support the conclusion that addictive behavior is not the product of “non-volitional forces.” If addictive behavior can be fully accounted for in terms of the addict’s choices, and if there is no need to postulate the existence of forces overwhelming the addict’s will, is there any reason not to hold the addict fully responsible for what he does?

Neurophysiology, on the other hand, has demonstrated that substance abuse causes significant changes in brain physiology, which appears to support the conclusion that addiction is a disease. If addiction corresponds to physical changes in the nervous system, then addiction is a disease, and addictive behavior is merely a symptom of the disease. We may be responsible for contracting a disease, but can we be held responsible for the symptoms once we have it?

Science does have a good many things to tell us about addiction, but so far whether or not the addict is responsible for what he does is not among them. The fact that choice theories–rational addiction, behavioral economics–can develop models in which addiction is the result of choice should not surprise us: Did anyone ever believe that addicts did not intend to do what they were doing? Did anyone ever believe that addicts did not choose to do what they did? The question has always been whether those choices were free, and whether the addict was fully in control of his choices. That is the question that the law must deal with, and in this paper I argue that choice theories have nothing to say to that question. Neurophysiology, on the other hand, has made remarkable strides in tracing down the effects of heavy drug use on the brain. But that behavior should effect brain changes is not by itself remarkable, and does not entail that behavior is not fully voluntary.

There are three possible conclusions. The first is that although science has yielded no results so far, we may hope for results in the future. The general nature of the arguments against drawing conclusions about responsibility from the existing literature makes that, if not entirely a vain hope, at least implausible. The second is that responsibility is simply one of the areas of human experience that is cut off from science; there must, therefore, be other ways of knowing what we do about addiction, control, and responsibility. And the third conclusion may be the most pessimistic of all, namely that responsibility itself is a confused notion, and that we should be skeptical about its role in the law.

Abstract: This Essay calls for a repositioning of two distinct legal regimes - inalienability and contract - that govern the imposition of liability for medical malpractice upon doctors and institutions, respectively. The inalienable right to tort remedies places opportunistic patients - who file unmeritorious lawsuits against doctors and increase the cost of medical care - in the same pool with honest patients, who cannot credibly promise doctors not to sue them opportunistically. The contract regime allows managed care organizations (MCOs) not to monitor their doctors, which enables bad doctors to pool with good doctors. MCOs' functioning as a platform in a two-sided market for medical services intensifies this pooling. Good doctors and honest patients consequently suffer. Good doctors earn less than they should and their prospect for being erroneously adjudicated liable for malpractice looms larger than it should. Honest patients subsidize the opportunists by paying for medical care more than they should.

A complete switchover between inalienability and contract would make good doctors, honest patients, and society at large better off. MCOs' institutional liability should become patients' inalienable right; the law also should stop treating the patient's entitlement to tort remedies as inalienable. Under this system, an MCO can offer patients a menu of agreements. The menu's baseline agreement must honor the patient's inalienable right to tort remedies; other agreements are free to limit the MCO's liability. The price-difference between the agreements would credibly inform patients about the quality of the MCO's doctors. To attract patients, the MCO would have to keep this difference at its lowest, which would motivate it to hire good doctors only. Honest patients would then agree to limit their entitlement to tort remedies and get inexpensive quality care in return. An opportunistic patient would prefer the full-liability agreement - a self-selection that would not only cost more, but would also expose the patient to defensive medicine.

Abstract: This paper investigates one of the largest pharmaceutical markets using a discrete choice model that allows marketing to affect product differentiation. Four main results emerge from an analysis of monthly panel data on antiulcer drugs from 1977 to 1993. Observed drug characteristics became less important relative to marketing in determining demand. Total marketing by all firms reduced product differentiation and raised the cost of entry significantly. Although increasingly rivalrous, marketing expanded the market, increasing social welfare. Finally, estimated returns to eliminating one adverse drug interaction in the pioneer drug approximately equal its first two years of sales.

Abstract: How should states classify embryos? The war has often waged between two classifications, people versus property. But what if a state assumed something in between, finding the embryo to be a potential person entitled to special respect? If a state adopted this position, how would the law affect medical research?

Presuming embryos constitute potential persons, the debate would continue with how to define “special respect.” The status of a potential person runs along a spectrum between property and personhood. How one defines “special respect” determines where the potential person falls along this spectrum. Special respect would create a spectrum of treatment that extends from a property-like limitation of ownership rights to something resembling rights afforded to an absolute person.

This comment theorizes about the impact of a state that statutorily regards an embryo as a potential person. Such a statute may assert that embryonic material with the active potential to develop into a live born offspring is a potential person due special respect. If special respect was presumed to lie on the person-oriented side of the spectrum, it would afford the potential person something akin to the most fundamental human rights. Such a definition draws into question the common practice of destroying embryos in IVF and stem cell research.

Part I assesses the current perception of embryos as persons, potential persons afforded due respect, and property. Part II discusses the potential insufficiency of characterizing embryos as persons and property. Part III analyzes variances within the spectrum of interpreting embryos as potential persons, including property that offers its owner a limited bundle of rights and persons who possess limited rights of their own. Part III also explains the value of treating embryos as more akin to persons than property. Part IV reflects on the implications that regarding an embryo as a person with limited rights would have upon medical technology. This includes an analysis on IVF, a consideration of traditional techniques for culturing stem cell lines, and an assessment of the most recent medical advances in deriving embryonic stem cells.

Abstract: Any human endeavor is prey to human error. The consequences of human error in the area of assisted reproductive technologies are magnified by our playing in the field of creation of new human lives and lifelong relationships. Stories of assisted reproductive technology (ART) mistakes continue to fascinate the media and popular culture, pain their multiple victims, and haunt the nightmares of ART participants, past, present, and future. Though there are many kinds of mistakes that can arise in these complex processes, this Article focuses on mistakes or mix-ups involving the accidental use of incorrect gametes (sperm, ova, and embryos) during in vitro fertilization (IVF) procedures. After examining the reported mistakes and the ways that courts have resolved issues of ART mistakes, this article looks at a proposed Model Act and suggests an alternative approach that has a particular sensitivity to women’s labor-based, gestational contributions to reproduction.

Abstract: The standard assumption in economic theory is that preferences are stable. In particular, they are not changed as a result of experience with the good/service/event. Behavioral scientists have challenged this assumption and claimed (providing evidence) that preferences are constantly changing when experience is accumulated. This paper tests the effect of experience on preferences for attributes of health-care events. We are using two very different samples and a methodology that facilitates the estimation of marginal utilities of various attributes of a composite non-traded health-care service. Discrete Choice Experimental design is employed for the analysis of samples of (1) women who gave birth, and (2) women who were diagnosed with breast cancer. For each group we had information on experience. In the case of women who gave birth, the sample was decomposed into 3 sub-samples: pregnant women with their first child (no experience); women after one delivery (single experience); and mothers after more than one delivery (multiple experience). Preferences of the 3 sub-groups have then been compared. The breast cancer patients reported the number of chemotherapy/radiation treatments they have already received, thus enabling the construction of an experience variable and testing for the effect of experience on preferences. The basic finding is that preferences for health-care attributes are significantly changed as a result of experience with the health event. However, the amount of experience is irrelevant.

Abstract: This empirical study focuses on medical negligence lawsuits filed in Oklahoma, addressing the following question. Do the number of medical negligence cases filed and the amount of subsequent lawsuit payouts indicate a need for tort reform in Oklahoma? First, the backdrop leading to the enactment of tort reform is set, followed by a presentation of a portion of Oklahoma's 2004 public hearings testimony regarding tort reform. Next, the availability of empirical data for Oklahoma is addressed. The results of the Oklahoma empirical study is provided, followed by a presentation of statistics regarding medical negligence payouts. Finally, the conclusions drawn from this empirical study are set forth, including the conclusion that Oklahoma should adopt a state-wide system whereby statistics regarding case filings are maintained.

Abstract: This Article reveals that many already issued and actively enforced medical biotechnology patents are invalid. Biologics, medical therapeutics derived through biotechnology techniques, are the fastest growing and most promising pharmaceutical sector. They represent a $30 billion a year industry that is anticipated to double in five years and already provides novel treatments for diabetes, cancer, and heart disease. Due to unforeseen consequences of century-old decisions, generic manufacturers currently are not able to make biologics even after biologic patents expire. As early biologics are just starting to go off-patent, this regulatory mix-up is now having a notable impact on the availability of biologics and significantly raising the cost of health care.

The generic biologics debate has dramatically heated-up recently, with the biotechnology and pharmaceutical industry arguing for the status quo, senators threatening legislation, and the Food and Drug Administration struggling to handle the situation. This Article exposes for the first time that industry’s own arguments have an unintended, striking consequence - their biologic patents fail enablement, and therefore are not valid in the first instance.

Abstract: The enclosed Article is the first comprehensive synthesis of two decades of empirical research on medical malpractice settlement. The portrait that emerges from this synthesis is both more reassuring and more complex than popular portrayals. Although the fit is not perfect, the merits generally drive the settlement process. Weak claims consistently fare the worst, toss-ups cases do better, and strong cases have the most success.

Prior scholarship on malpractice outcomes has understated the strength of this correlation because it has focused principally on the impact of negligence on the settlement rates and has largely ignored the importance of settlement amount. The studies examining the relationship between settlement rate and case quality have invited mixed reactions because they have found a correlation that, while strong, leaves room for improvement. In 10-20 percent of the weakest cases, the plaintiff receives a settlement payment. In a similar fraction of the strongest cases, the plaintiff recovers nothing.

Yet, settlement rates, standing alone, paint a misleading picture. Equally important is the relationship between the strength of the plaintiff’s case and the size of the payment received in settlement. As long as the payments received by the plaintiffs in weak and toss-up cases are appropriately discounted to reflect case quality, then settlement of the case is fully consistent with fair treatment of the defendant. For that reason, settlement rate data inherently overstates the prevalence of “error.” Settlement size must be considered as well.

In malpractice litigation, the amount paid to settle a case is routinely adjusted to match the strength of the plaintiff’s case. Although only a few studies have collected this data, they show that payments in weak and toss-up cases are heavily discounted. In fact, the data on settlement size suggest that defendants are able to extract an even deeper discount than is warranted by the merits. The ability of insurance companies to extract this discount suggests that malpractice defendants enjoy a systematic advantage in bargaining power. Although the source of this asymmetry has yet to be determined, the studies justify several interesting hypotheses.

Abstract: This article considers several parameters of the late twentieth and early twenty-first-century debate in the U.S. about ethics, politics, science, and ideology (popularly referred to as the "culture wars"). The article focuses, in particular, on shifting understandings of the embryo. The article reviews developments in science (especially the advent of stem-cell research and cloning) that have affected understandings of embryo, the history of debate about abortion in the U.S., and the place of discourse about abortion in a more far-reaching social debate about family, personal relationships, and the scope of personhood in the U.S.

Dimensions of Informed Consent to TreatmentInternational Journal of Gynecology and Obstetrics, Vol. 85, pp. 309-314, 2004 Bernard Dickens and Rebecca J. Cook University of Toronto - Faculty of Law and University of Toronto - Faculty of Law

Abstract: Modern law approaches patients’ consent to treatment not only through liability for unauthorized touching, namely criminal assault and/or civil (non-criminal) battery, but also through liability for negligence. Physicians must exercise appropriate skill in conducting procedures, and in providing patients with information material to the choices that patients have to make. The doctrine of informed consent serves the ethical goal of respecting patients’ rights of self-determination. Information is initially pitched at the reasonable, prudent person in the patient’s circumstances, and then fine-tuned to what is actually known about the particular patient’s needs for information. Elements to be disclosed include the patient’s prognosis if untreated, alternative treatment goals and options, the success rate of each option, and its known effects and material risks. Risks include medical risks, but also risks to general well-being such as economic and similar reasonable interests. Consent is a continuing process, not an event or signed form.

Abstract: This paper is a case study of the use of public use administrative data for the estimation of empirical relations when key dependent variables are not available in the data. It is shown that the out-of-hospital mortality rates can be identified using the patient discharge data without post-discharge death records. Using data on the lengths of hospitalizations and out-of-hospital spells, the mortality rates before and after discharge as well as discharge and re-hospitalization rates are estimated for a sample of heart-attack patients hospitalized in California between 1992 and 1998. The results suggest that ignoring variation of discharge rates among hospital types could be misleading in evaluating hospital performance regarding mortality risks.

Obstetric Fistula: The Challenge to Human RightsInternational Journal of Gynecology and Obstetrics, Vol. 87, pp. 72-77, 2004Rebecca J. Cook and Bernard Dickens University of Toronto - Faculty of Law and University of Toronto - Faculty of Law

Abstract: Obstetric fistula can be explained to result from different causes. These holes in the tissue wall between the vagina and bladder and/or rectum are most prevalent in resource-poor countries, attributable to prolonged obstructed labour and absent or inaccessible remedial prenatal services. Obstructed labour is often due to small pelvic size, resulting from women’s youth and premature childbearing and/or malnutrition. Poverty at national health-service and family levels often predisposes pregnant populations to suffer high rates of fistula. Global estimates showing up to 100,000 new cases each year and 2 million affected girls and women are probably gross underestimates. Fistula devastates lives of sufferers, who are often expelled by husbands and become isolated from their families and communities. Failures of states to provide prenatal preventive care (including medically indicated cesarean deliveries) and timely fistula repair violate women’s internationally recognized human rights, especially to healthcare in general and reproductive healthcare in particular.

Abstract: We analyze mechanisms to kidney exchange with good samaritan donors where exchange is feasible not only among donor-patient pairs but also among such pairs and non-directed alturistic donors. We show that you request my donor-I get your turn mechanism (Abdulkadiroglu and Sonmez [1999]) is the only mechanism that is Pareto efficient, individually rational, strategy-proof, weakly neutral and consistent.

Abstract: The debate over both cloning and stem cell research has been intense and polarizing. It played a significant role in the recently completed presidential campaign, mentioned by both candidates on the stump, at both parties' conventions, and was even taken up directly during one of the presidential debates. The topic has been discussed and debated almost continuously by the members of the legal, scientific, medical, and public policy commentariat. I believe that it is a heartening tribute to our national polity that such a complex moral, ethical, and scientific issue has become a central focus of our political discourse. But, as you have no doubt noticed, the content of the discourse itself has been sometimes quite impoverished and unsatisfying. No one camp in this debate is solely to blame for these difficulties - partisans on all sides bear some measure of responsibility for the current state of the public discourse. In the interests of improving the quality of public deliberation and discussion on this matter, I will provide a few modest suggestions for how the public debate might be improved. I begin with a few general observations applicable to both domains under consideration today, stem cell research and cloning. Then I focus on each separately; first, directing my comments to stem cell research, and then turning to the distinct (though obviously closely related) matter of cloning.

Abstract: The enormous significance of the Bush stem cell funding policy has been evident since its inception. The announcement of the policy on August 9, 2001 marked the first time a U.S. president had ever taken up a matter of bioethical import as the sole subject of a major national policy address. Indeed, the August 9th speech was the President's first nationally televised policy address of any kind. Since then, the policy has been a constant focus of attention and discussion by political commentators, the print and broadcast media, advocacy organizations, scientists, elected officials, and candidates for all levels of office (including especially the 2004 Democratic nominee for President, Senator John Kerry, who made his opposition to the Bush policy a centerpiece of his domestic campaign, mentioning it explicitly in his acceptance speech at the Democratic National Convention). The biotechnology industry has taken a keen interest in stem cell research as a possible avenue for medical therapies; one study suggests that as of 2002 private sector companies had spent an aggregate of $208 million on research and development of stem cell technologies. In response to the policy, there has been a flurry of state legislation proposed and enacted, with some states affirming and others condemning the Administration's approach. Finally, the great prominence of the national and international debate on human cloning has drawn further attention to the issue of embryonic stem cell research (and by extension, the Bush policy), given that one application of somatic cell nuclear transfer is the production of cloned human embryos from which stem cells may be derived (so-called Therapeutic Cloning).

To date, the significance of the Bush stem cell policy has been framed and publicly debated in terms of its practical import: Does it impede the scientific and medical progress that the research seems to promise? Is it adequately protective and respectful of embryonic human life? Aside from its great practical significance, however, the Bush policy is arguably one of the most important recent legal developments for the field of bioethics for an additional reason: its deep pedagogical significance. The Bush policy provides an unparalleled window into the nature and substance of bioethical regulation within the unique framework of the American system of government. And it does so in dramatic fashion, against the backdrop of some of the most enduring and vexing questions in all of bioethics: What is owed to developing human life, and how does this obligation stand in relation to the aim of science to advance knowledge with the ultimate aspiration of alleviating human suffering? Reflecting on the nature and scope of the policy yields insights into a number of crucial matters that are central to the problem of whether and how to govern science and medicine according to bioethical principles. This Essay will briefly explore five areas in which the Bush policy is thus instructive: (1) the conceptual understanding of regulation as a legal category; (2) the principles of federalism; (3) the significance of federal funding; (4) the nature of governance according to a particular type of moral principle (e.g., bright line); and (5) the influence of political prudence and respect for pluralism.

Abstract: For many years, institutional psychiatry was a major tool in the suppression of political dissent. Moreover, it appears painfully clear that, while the worst excesses of the past have mostly disappeared, the problem is not limited to the pages of history. What is more, the revelations of the worst of these abuses (and the concomitant rectification of many of them) may, paradoxically, have created the false illusion that all the major problems attendant to questions of institutional treatment and conditions in these nations have been solved. This is decidedly not so.

Remarkably, the issue of the human rights of persons with mental disabilities had been ignored for decades by the international agencies vested with the protection of human rights on a global scale. Within the legal literature, it appears that the first time disability rights was conceptualized as a human rights issue was as recently as 1993 when, in a groundbreaking article, Eric Rosenthal and Leonard Rubenstein first applied international human rights principles to the institutionalization of people with mental disabilities.

For people with mental disabilities, in particular, the development of human rights protections may be even more significant than for people with other disabilities. Like people with other disabilities, people with mental disabilities face degradation, stigmatization, and discrimination throughout the world today. But unlike people with other disabilities, many people with mental disabilities are routinely confined, against their will, in institutions, and deprived of their freedom, dignity, and basic human rights. People with mental disabilities who are fortunate enough to live outside of institutions often remain imprisoned by the social isolation they experience, often from their own families. They are not included in educational programs, and they face attitudinal barriers to employment because they have not received the education and training needed to obtain employment or because of discrimination based on unsubstantiated fears and prejudice. Only recently have disability discrimination laws and policies in the United States and elsewhere focused on changing such attitudes and promoting the integration of people with disabilities into our schools, neighborhoods, and workplaces.

The question remains, however: to what extent has institutional, state-sponsored psychiatry been used as a tool of political suppression, and what are the implications of this pattern and practice? In Part I of this article, I discuss the first revelations of the dehumanization inflicted on persons with mental disabilities, primarily (but not exclusively) in Soviet Bloc nations. In Part II, I discuss developments after these revelations were publicized. In Part III, I weigh the extent to which the post-revelation reforms have been effective and meaningful. In Part IV, I explain the meanings of sanism and pretextuality, and discuss how they relate to the topic at hand. Then, in Part V, I raise questions that have not yet been answered, and that, I believe, should help set the research agendas of those thinking about these important issues.

The Puzzle of IVFDena S. Davis Cleveland State University - Cleveland-Marshall College of Law

Abstract: This essay seeks to address a puzzling element of the current political and legal struggles over abortion in the United States: if, as pro-life activists insist, embryos are morally equivalent to born, living persons, then why do these activists not oppose in vitro fertilization (IVF) as aggressively as they oppose abortion? IVF accounts for a significant number of destroyed embryos. Constitutionally, IVF appears to be a much more vulnerable target than abortion. And yet, legislative and political attempts to attack and restrict IVF are few, while attempts to erode women's capability to terminate pregnancies are a constant feature of our political and legal landscape.

Abstract: The bitter dispute over the proper treatment of Theresa Marie Schiavo - a severely brain-damaged woman, unable to communicate and with no living will or advance directive - has garnered enormous attention in the media, both national and international. What began as a heated disagreement between Ms. Schiavo's husband and parents mushroomed into a massive political conflict involving privacy advocates on one side, and right-to-life and disability activists on the other. The battle raged on the editorial pages of the world's newspapers, in the courts, and ultimately, in the legislative and executive branches of the Florida state government. After nearly three years of acrimonious litigation between Michael Schiavo (Ms. Schiavo's husband) and the Schindler family (Ms. Schiavo's parents), a Florida court ordered that nutrition and hydration for Ms. Schiavo be discontinued. Six days after implementation of the court's order, the Florida Legislature passed "Terri's Law," authorizing the Governor, under certain prescribed circumstances, to issue a one-time stay of court-ordered withdrawal of life-sustaining measures, and to appoint a guardian ad litem to review the matter and report back to the executive branch and the chief judge of the relevant Florida court. Pursuant to this new authority, the Governor stayed the order issued by the court, and nutrition and hydration were restored to Ms. Schiavo.

To date, the public debate on this matter has been framed as a conflict between or a balancing of abstract concepts such as "the right to die," "the sanctity of life," and "the rights of the disabled." Little scholarly attention has been paid, however, to an enormously important question at the heart of this matter, namely, what the proper roles of the various branches of government are in a case such as Schiavo's. The proper question is not whether the government has a role in a dispute such as this - it clearly became involved once the matter moved to the state courts - but rather how the government should be involved. Which branch, if any, should have the last word in such a dispute? In these cases, should the relationship between governmental branches be hierarchical or complementary? Which branch of government is best situated to resolve these disputes? This Article, using the Schiavo case as the relevant point of departure, essays to address these questions. Specifically, the questions presented are twofold: (1) Were the Florida Legislature's (and by extension, the Governor's) actions in the Schiavo case consistent with the constitutional principles of separation of powers? (2) If so, did the actions of the executive and legislative branches in this case promote or undermine the purposes and logic of the Florida laws governing end-of-life decisionmaking, taken as a whole? That is, is Terri's Law wise public policy from a structural, governmental view?

Abstract: A survey of the commentary following the conclusion of the Theresa Marie Schiavo matter leaves one with the impression that the case was a victory for the cause of autonomy and the right of self-determination in the end-of-life context. In this essay, I seek to challenge this thesis and demonstrate that, contrary to popular understanding, it is the defenders of autonomy and self-determination who should be most troubled by what transpired in the Schiavo case. In support of this claim, I will first set forth (in cursory fashion) the underlying aim of the defenders of autonomy in this context. Then, I will provide a brief sketch of how the law - both as enacted and interpreted - might ideally serve to promote and defend the goods of autonomy and self-determination. I will thus assess the process and outcome of the Schiavo case by carefully examining the positive law governing the case, as well as the specific evidence relied on by the Florida courts to assess Ms. Schiavo’s actual wishes (the touchstone of autonomy). Moreover, I will contrast the manner in which the Florida courts evaluated this evidence with the seemingly consistent and uniform approach taken by courts from other jurisdictions. I will additionally explore the significance of the Florida courts’ decision to focus the majority of their resources and time on inquiries not oriented towards Ms. Schiavo’s actual wishes, but rather on matters relating to paternalistic considerations, such as her present and future quality of life. In light of the foregoing analysis, I conclude that the Schiavo matter cannot rightly be understood as a victory for self-governance at the end of life. To the contrary, it is instead a cautionary tale of what can happen when the legal preconditions for the exercise of autonomy are absent or ignored.

Abstract: Neuroscientists have made surprising advances in identifying drugs to dampen the emotional intensity of traumatic memories. Such drugs hold promise for those plagued by painful memories of terrorism, military conflict, assault, car accidents, and natural disasters. Yet some ethicists, including members of the President's Council on Bioethics, claim that memory-dampening drugs may lead us to forget people and events that we are obligated to remember. They also fear that such drugs will reduce the value of eyewitness testimony and help criminals hide their tracks.

After describing the legal and ethical implications of memory dampening, I argue that the Council is unnecessarily alarmed. While memory is an essential component of personal identity and we do sometimes have obligations to remember, the Council's concerns are founded on controversial premises that unjustifiably privilege our natural cognitive abilities. Furthermore, while perhaps we ought sometimes restrict memory dampening, a general prohibition would be unjustified: We have a deeply personal interest in controlling our own minds that entitles us to a certain freedom of memory.

Abstract: According to institutional sociology, hospitals will respond to external environmental pressures and adopt Activity-Based-Costing (ABC). This theory overemphasizes conformity and fails to consider the advantages of organizational non-conformance. A conflict of interests between physicians and management leads to physician resistance to accepting ABC. This paper investigates the Spanish government's response to this resistance by creating new public foundation hospitals, and involves a case study of the Alcorcón foundation hospital. Population ecology is offered as an explanation for the emergence of new entities as a result of inert existing entities' resistance to reform.

The New York Times ran an informative piece on the increasing number of employees (mostly women) who are struggling to keep their jobs and care for aging relatives. The article notes the fact that most employers do not have policies that provide leave or other services to help an employee care for elderly family members and that childcare policies are not a good fit for these employees. It states,

According to the Society for Human Resource Management, which
represents more than 200,000 human resource and other corporate
officials, 39 percent of its members said in 2003 that elder care
benefits were "too costly to be feasible." Only 1 percent of their
companies subsidized any elder care benefits last year. And only 3
percent offered the emergency backup care — subsidized or otherwise —
that experts say saves money by keeping workers at work. . . .

"These benefits fall under the same umbrella but are
fundamentally different," Mr. Gatti said. "Child care programs are
relatively straight-forward and easy to administer compared to elder
care, which is a maze with lots of sharp corners and dark secluded
places."

The distinctions between child care and elder
care have become apparent as the first of the 77 million baby boomers
turn 60 and their parents live past 85, joining the fastest-growing
segment of the population.

The most obvious is that children's
schedules are predictable — a school holiday next Monday — while
elderly parents' needs — a trip to the emergency room — are
crisis-driven. Also, children are raised at home; an elderly parent
often lives far away.

Guiding the decisions of an elderly parent also requires mastery of arcane legal, financial and medical matters.

It is an interesting piece and provides insight into an issue that will require action on someone's part to make it possible for employees to continue working while dealing with a host of issues that arise when family members require greater attention as they age. [bm]

Geneticists have mixed DNA from the roundworm C. elegans and pigs to produce swine with significant amounts of omega-3 fatty acids - the kind believed to stave off heart disease.

Researchers hope they can improve the technique in pork and do the same in chickens and cows. In the process, they also want to better understand human disease.

"We all can use more omega-3 in our diet," said Dr. Jing Kang, the Harvard Medical School researcher who discovered the omega-3-making gene in the worm.

Kang is one of 17 authors of the paper appearing Sunday in an online edition of the journal Nature Biotechnology.

The cloned, genetically engineered pigs are the latest advance in the agricultural biotechnology field, which is struggling to move beyond esoteric products such as bug-repelling corn and soy resistant to weed killers.

The day will yet come, mark my words (and remember Woody Allen's brilliant 1973 film, "Sleeper"), when we'll be adding a side order of bacon or sausage to our breakfasts for the heart-healthy benefits. [tm]

As reported by the AP (Yahoo), the Raich case is going to be argued in the 9th Circuit on Monday, this time to urge the narrower "right to life theory: that marijuana should be allowed if it is the only viable option to keep a patient alive or free of excruciating pain":

It would apply only to the sickest patients and their suppliers, regardless of whether they live in one of the 11 mostly Western states that allow medical marijuana.

"A victory would affect people who are very seriously ill, facing death or great physical suffering," said Randy Barnett, a Boston University law school professor working on the case.

The case was brought by Angel Raich, a 40-year-old mother of two from Oakland who suffers from scoliosis, a brain tumor, chronic nausea and other ailments. She uses marijuana every couple of hours to ease her pain and bolster her appetite.

"She'd probably be dead without marijuana," said her doctor, Frank Lucido, who has recommended marijuana for some 3,000 patients. "Nothing else works."

The DOJ lawyers deny there is a "fundamental right to distribute, cultivate or possess marijuana." The Supreme Court upheld the constitutionality of the Controlled Substances Act, as applied to state medical marijuana laws, in 2005 in Gonzales v. Raich. [tm]

DHHS Computer System Weaknesses Leave Medical Data Vulnerable, GAO Finds -- Department of Health and Human Services (DHHS) computer networks have significant weaknesses, which increases the risk of unauthorized access to medical data, the Government Accountability Office (GAO) found in a recent report. The report, “Information Security: Department of Health and Human Services Needs to Fully Implement Its Program,” (GAO-06-267), was issued in response to a request by Senate Finance Committee Chairman Charles Grassley (R-IA).

OIG Says CMS Needs To Improve Performance Evaluations Of Medicare Contractors Used To Fight Fraud -- The Centers for Medicare and Medicaid Services (CMS) needs to do a better job of evaluating the performance of the contractors it uses to detect and deter fraud in the Medicare program, the Department of Health and Human Services Office of Inspector General (OIG) found in a recent report. CMS’ contractor performance evaluation reports were missing key information about the results achieved by these contractors in detecting fraud and abuse, making it difficult to determine whether to renew their contracts, the OIG noted.